WO2015114578A1 - Dispositif pour traiter et transporter des instruments médicaux de façon protégée - Google Patents

Dispositif pour traiter et transporter des instruments médicaux de façon protégée Download PDF

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Publication number
WO2015114578A1
WO2015114578A1 PCT/IB2015/050709 IB2015050709W WO2015114578A1 WO 2015114578 A1 WO2015114578 A1 WO 2015114578A1 IB 2015050709 W IB2015050709 W IB 2015050709W WO 2015114578 A1 WO2015114578 A1 WO 2015114578A1
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WO
WIPO (PCT)
Prior art keywords
display
sensor
electronic state
state display
medical instrument
Prior art date
Application number
PCT/IB2015/050709
Other languages
English (en)
Inventor
Fabio Zardini
Original Assignee
Steelco S.P.A.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Steelco S.P.A. filed Critical Steelco S.P.A.
Priority to US15/115,788 priority Critical patent/US20170172397A1/en
Priority to EP15710884.6A priority patent/EP3110460B1/fr
Publication of WO2015114578A1 publication Critical patent/WO2015114578A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/12—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements
    • A61B1/121—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements provided with means for cleaning post-use
    • A61B1/123—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements provided with means for cleaning post-use using washing machines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00002—Operational features of endoscopes
    • A61B1/00043—Operational features of endoscopes provided with output arrangements
    • A61B1/00045—Display arrangement
    • A61B1/00048—Constructional features of the display
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00131—Accessories for endoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00142—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with means for preventing contamination, e.g. by using a sanitary sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/12—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements
    • A61B1/121—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements provided with means for cleaning post-use
    • A61B1/125—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements provided with means for cleaning post-use using fluid circuits
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/70—Cleaning devices specially adapted for surgical instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/24—Apparatus using programmed or automatic operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/26—Accessories or devices or components used for biocidal treatment
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B08—CLEANING
    • B08B—CLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
    • B08B9/00—Cleaning hollow articles by methods or apparatus specially adapted thereto 
    • B08B9/02—Cleaning pipes or tubes or systems of pipes or tubes
    • B08B9/023—Cleaning the external surface
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B08—CLEANING
    • B08B—CLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
    • B08B9/00—Cleaning hollow articles by methods or apparatus specially adapted thereto 
    • B08B9/02—Cleaning pipes or tubes or systems of pipes or tubes
    • B08B9/027—Cleaning the internal surfaces; Removal of blockages
    • B08B9/032—Cleaning the internal surfaces; Removal of blockages by the mechanical action of a moving fluid, e.g. by flushing
    • B08B9/0321—Cleaning the internal surfaces; Removal of blockages by the mechanical action of a moving fluid, e.g. by flushing using pressurised, pulsating or purging fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/70—Cleaning devices specially adapted for surgical instruments
    • A61B2090/701—Cleaning devices specially adapted for surgical instruments for flexible tubular instruments, e.g. endoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/12—Apparatus for isolating biocidal substances from the environment
    • A61L2202/121—Sealings, e.g. doors, covers, valves, sluices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/12—Apparatus for isolating biocidal substances from the environment
    • A61L2202/122—Chambers for sterilisation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/14—Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/16—Mobile applications, e.g. portable devices, trailers, devices mounted on vehicles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/17—Combination with washing or cleaning means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/18—Aseptic storing means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B08—CLEANING
    • B08B—CLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
    • B08B2203/00—Details of cleaning machines or methods involving the use or presence of liquid or steam
    • B08B2203/02—Details of machines or methods for cleaning by the force of jets or sprays
    • B08B2203/0247—Hose joints, e.g. quick joints, rotating joints

Definitions

  • Forms of embodiment of the present invention concern a device to process, in particular to wash, sterilize and dry medical instruments and to transport them in a protected manner inside a hospital or surgery, in particular flexible endoscopes, both during their washing and processing and afterward.
  • the device according to the present invention can be used to wash and transport, in a protected manner, medical instruments of the tubular type made of various materials, in particular metal, plastic and/or rubber, used in medicine to explore and examine using optical apparatuses or to empty natural cavities of the organism, and introduced naturally or artificially, such as colonoscopes, bronchoscopes and gastroscopes.
  • Endoscopic instruments used to examine internal parts of the human body or animals, are known.
  • Endoscopic instruments typically include a flexible operating tube, also called insertion tube, normally with a diameter from 0.5 to 20 mm and a length from 300 to 4000 mm, suitable to be inserted into the patient's body, with a length and diameter that vary according to applications.
  • Channels may be disposed or made inside the flexible operating tube, of various sizes and for various uses, for example for biopsies, TV camera inspections, for lighting, to irrorate air and/or water. Because of the purposes for which they are used, the endoscopes must be washed and disinfected carefully after use.
  • Washer machines are known, for washing medical instruments such as endoscopes used during clinical practice.
  • Known machines of this type are described for example in the European patent EP-B- 1.949.868 (EP'868) and in the European patent application EP-A-2.445.438 (EP'438).
  • Known washer machines typically include a washing chamber, in which the complete washing is carried out of both the external surfaces and internal surfaces and the channels of the endoscopic instrument, using washing liquids such as water and detergents or chemical disinfectants, for example based on glutaraldehyde or peracetic acid.
  • washing liquids such as water and detergents or chemical disinfectants, for example based on glutaraldehyde or peracetic acid.
  • the external surface of the endoscopic instrument is typically treated by immersing it in a container, for example an auxiliary pipe, positioned in the washing chamber and connected to the washing circuit by a sleeve.
  • the treatment can also be done using a washing device as described for example in EP'868 or EP'438.
  • the internal surfaces are treated by connecting flexible tubes to the internal channels of the endoscopic instrument.
  • a container is normally provided, to load the endoscopic instrument inside the washing chamber, in which the endoscopic instrument is positioned.
  • An example of a loading container is described in EP'868 or EP'438.
  • EP-B- 1.696.969 describes an apparatus for re-processing endoscopes equipped with several channels, held together by a sheath, which includes in its essential components a processing machine and a case that can be hermetically closed and that forms a chamber to receive an endoscope to be re-processed.
  • the international application PCT/IB2013/061 107 describes a machine for reprocessing an endoscope that allows to facilitate the transport of the endoscope in the various sites where it is used and which guarantees the sterility of the endoscope contained in the chamber after re-processing also during transport to its place of use.
  • the sterilization machine includes a fixed part and a mobile part which can be moved away from, nearer to, and reciprocally coupled with the fixed part and includes a tank suitable to receive the endoscope to be re- processed and a lid to hermetically close the tank.
  • the transport and protection device may be opened, inadvertently or not, and inevitably the medical instrument will no longer be sterile.
  • Re-closing the transport and protection device it may be possible to simulate that it was never opened after sterilization, in which case the final user may not be aware that the medical instrument is no longer sterile, but has been altered in some way, and will therefore use a medical instrument that in practice is not fit for purpose, and hence is potentially dangerous for the patient's health.
  • the Applicant has devised, tested and embodied the present invention to overcome the shortcomings of the state of the art and to obtain these and other purposes and advantages.
  • the device includes a containing body, in which a medical instrument is placed, and a closing body.
  • the containing body and the closing body are configured mobile with respect to each other, in order to define a hermetically closed condition and an open condition.
  • the device includes at least one sensor configured to automatically detect a variation between the open condition and the hermetically closed condition and to transmit a corresponding signal, and an electronic state display configured to receive the signal from the sensor and to display toward the outside information regarding the current state associated specifically to the signal received.
  • a device to process and transport medical instruments in a protected manner comprising a containing body, provided with a housing in which to place a medical instrument, and a closing body, in which the containing body and the closing body are configured mobile with respect to each other, in order to define a hermetically closed condition and an open condition.
  • the device includes:
  • At least one sensor configured to automatically detect a variation between the open condition and the hermetically closed condition and to transmit a corresponding signal, said sensor being a position sensor and comprising at least two sensitive elements, of which one sensitive element disposed on the containing body and one sensitive element disposed on the closing body;
  • an electronic state display configured to receive said signal from the sensor and to display toward the outside information regarding the current state associated specifically to the signal received, said electronic state display being provided with a processing unit configured at least to perform a processing of the signal received from the sensor and to command a display of information regarding a corresponding state.
  • a setting member configured to set a state of completed processing of the medical instrument by transmitting a corresponding signal to the electronic state display.
  • the electronic state display is configured to display at least a sterile state of the medical instrument associated with the hermetically closed condition and a non-sterile state of the medical instrument associated with the open condition and/or in the case of passage from the hermetically closed condition to the open condition.
  • the electronic state display is provided on the closing body, or on the containing body.
  • the device to process and transport medical instruments in a protected manner comprises a source of electric energy on board, configured to autonomously feed electric energy at least to the electronic state display.
  • the electronic state display comprises one or more selectively activated light sources.
  • the electronic state display comprises a display screen.
  • the display screen is touch sensitive.
  • the electronic state display is configured to display information for each state by means of a specific letter, combination of letters, writings and/or a graphical sign and/or a symbol or combination of symbols and/or one or more dedicated colors or other visual/optical signals and combinations thereof.
  • the electronic state display comprises a user input interface.
  • the electronic state display is configured to display information regarding the specific state in a manner that is non-reversible and/or non-modifiable without authorization.
  • the senor is chosen from either a contact sensor or a proximity sensor.
  • the setting member comprises an external connector or socket, able to support the transmission and reception of an electric power signal, or data, or a combination of electric power and data signal.
  • the setting member comprises the input interface.
  • Forms of embodiment described here also concern a method to process and transport medical instruments in a protected manner. According to one form of embodiment the method includes:
  • the method also includes:
  • the sensor being a position sensor and comprising at least two sensitive elements, of which one sensitive element disposed on the containing body and one sensitive element disposed on the closing body;
  • the electronic state display being provided with a processing unit that at least performs a processing of the signal received from the sensor and commands a display of information regarding a corresponding state; - setting a state of completed processing of the medical instrument by means of a setting member, transmitting a corresponding signal to the electronic state display.
  • FIG. 1 is a perspective view of a device to process and transport medical instruments in a protected manner in a closed condition in accordance with forms of embodiment described here;
  • FIG. 2 is a perspective view of a device to process and transport medical instruments in a protected manner in an open condition in accordance with forms of embodiment described here;
  • FIG. 3 is a perspective view of a device to process and transport medical instruments in a protected manner in a closed condition in accordance with other forms of embodiment described here;
  • FIG. 4 is a perspective view of a device to process and transport medical instruments in a protected manner in an open condition in accordance with other forms of embodiment described here.
  • a medical instrument as used in forms of embodiment described here can be a medical instrument usable in a hospital or surgery, in particular a flexible endoscope.
  • medical instruments usable in forms of embodiment described here can be medical instruments of the tubular type made of various materials, in particular metal, plastic and/or rubber, used in medicine to explore or examine using optical apparatuses, or to empty natural cavities in the body and introduced naturally or artificially, such as for example colonoscopes, bronchoscopes and gastroscopes.
  • Forms of embodiment described here can provide a device 10 to process and transport medical instruments 12 in a protected manner (see fig. 2 for example), such as endoscopic instruments or endoscopes, in accordance with the present description.
  • the device 10 can include a containing body 14 and a closing body 16.
  • the containing body 14 can provide a housing 18 inside it (see figs. 2 and 4 for example) in which to place a medical instrument 12 to be processed.
  • the containing body 14 and the closing body 16 can be configured mobile with respect to each other, in order to define a closed condition of the device 10 and an open condition of the device 10.
  • the containing body 14 and the closing body 16 can be mobile thanks to reciprocal hinging around an axis of rotation X.
  • the hinging can be at the front or side, so that the opening/closing movement can for example be drop-down or like a book.
  • the device 10 In the closed condition, the device 10 encloses a processing chamber inside it in which the re-processing and/or sterilization of the medical instrument 12 can take place, both of its external surfaces and its internal surfaces.
  • the processing chamber can thus be defined by the housing 18, that is, by the bottom and the lateral walls that delimit it, and by the closing body 16, for example by one of its internal walls 17 (see fig. 2 for example).
  • the processing, re-processing and/or sterilization operations of the medical instrument 12 can, and normally must, take place with the device 10 in the closed condition.
  • the device 10 is configured to guarantee the airtight seal in the closed condition.
  • perimeter packings 19 can be provided (see fig. 2 for example) to guarantee the hermetic seal of containing body 14 and closing body 16, in the closed condition.
  • clamping members 20 can be provided to clamp containing body 14 and closing body 16 from the outside. In this way, after the medical instrument 12 has been processed and sterilized, and thanks to the airtight seal of the closing, it keeps the desired conditions of sterility suitable for its subsequent uses.
  • the device 10 can include one or more entrances 22 for processing fluids, in particular washing, sterilization and drying, of the medical instrument 12 provided in the housing 18.
  • the entrances 22 are typically connectable on one side to fluidic/hydraulic exits of a washer machine for endoscopic instruments, and on the other side, directly or indirectly, to the inside of the containing body 14.
  • the entrances 22 can be connected to connectors 24 of the medical instrument 12 placed therein, in order to reprocess the internal surfaces, just as they can open directly to the inside of the processing chamber, for example to process the external surfaces of the medical instrument 12.
  • the one or more entrances 22 can be hydraulic connectors for example, or fluidic in general, possibly suitable to operate with liquids and/or fluids under pressure.
  • connectors of the rapid type can be provided.
  • the entrances 22 can be provided on the containing body 14 and/or on the closing body 16, at the front or at the back, or again laterally, above or below, according to needs.
  • the device 10 is provided externally with an electronic state display 26.
  • the electronic state display 26 is configured to display a multiplicity of information correlated to a plurality of states associated to the device 10 or to the medical instrument 12 contained therein.
  • the electronic state display 26 is directly, and without difficulty, visible from the outside for a final user who can thus immediately recognize the information that it transmits and can proceed accordingly.
  • the electronic state display 26 can be configured to display at least a sterile state of the medical instrument 12, typically associated to the hermetically closed condition, and a non-sterile state of the medical instrument 12, associated to the open condition.
  • the electronic state display 26 can be configured to automatically change information displayed relating to a displayed state depending on the closed or open condition that the device 10 can assume on each occasion.
  • the electronic state display 26 can be provided on the closing body 16, for example in a front, upper or lateral position.
  • the electronic state display 26 can be provided on the containing body 14, in this case too for example in a front, upper or lateral position.
  • the closing body 16 can be a closing lid.
  • the device 10 can include a source of electric energy 28 on board, configured to autonomously feed electric energy at least to the electronic state display 26. In this way it is possible to render the electronic state display 26 energy autonomous.
  • the source of electric energy 28 can be integrated or incorporated in the closing body 16.
  • the source of electric energy 28 can be integrated or incorporated in the containing body 14.
  • the source of electric energy 28 can be protected in a suitable housing chamber.
  • the source of electric energy 28 can include a battery or primary or secondary battery, or electric load accumulator. Several batteries or primary or secondary batteries can be provided, in series, or a pack of batteries. Therefore the source of electric energy 28 may not be rechargeable, and in this case it is disposed of and replaced, or rechargeable, such as a buffer battery.
  • the device 10 can be provided with a sensor 30 (see fig. 1 for example) configured to automatically detect a variation between the open condition and the closed condition of the device 10 and to transmit a corresponding signal to the electronic state display 26.
  • a sensor 30 see fig. 1 for example
  • the electronic state display 26 can be configured to receive the signal from the sensor 30 and to process it, so as to display toward the outside, among possible displayable states, information on the current state of the device 10 and/or the medical instrument 12 contained therein, which current state is specifically associated to the signal received, so that the information displayed is received intuitively by the final user.
  • the electronic state display 26 can be connected to the sensor 30 via cable, or by wireless connections.
  • the electronic state display 26 can be provided with a processing unit 32 configured at least to carry out the processing of the signal received and to command, accordingly, the display of a specific piece of information correlated to the corresponding state.
  • the processing unit 32 can include a system controller, a microcontroller, a PLC (Programmable Logic Controller), a processor or micro- processor (CPU), provided with an EPROM (Erasable Programmable Read-Only Memory) card, or EEPROM (Electrically Erasable Programmable Read-Only Memory) card, or other similar electronic control/processing/memorization systems.
  • a system controller a microcontroller, a PLC (Programmable Logic Controller), a processor or micro- processor (CPU), provided with an EPROM (Erasable Programmable Read-Only Memory) card, or EEPROM (Electrically Erasable Programmable Read-Only Memory) card, or other similar electronic control/processing/memorization systems.
  • the system controller can include a central processing unit (CPU), a memory, and auxiliary circuits (or I/O).
  • the CPU can be any form of processor for computers that can be used in industrial regulations to control different chamber processes and hardware devices (such as conveyors, optical inspection units, motors, fluid delivery devices etc.) and to monitor the system and the chamber processes (such as substrate position, process times, detection signals etc.).
  • the memory can be connected to the CPU and can be one or more of those readily available, such as RAM (Random Access Memory), ROM (Read Only Memory), floppy disc, hard disc, mass memory, or any other form of digital, local or remote storage. Possible software instructions and data can be encoded and memorized in the memory for example to command the CPU.
  • the auxiliary circuits can also be connected to the CPU to help the processor in a conventional manner.
  • the auxiliary circuits can include for example, at least one of: cache circuits, feed circuits, clock circuits, input/output circuitry, subsystems and suchlike.
  • the electronic state display 26 can include one or more light sources that can be selectively activated, for example a LED (Light Emitting Diode), or an array of LEDs.
  • a LED Light Emitting Diode
  • the electronic state display 26 can include one or more light sources that can be selectively activated, for example a LED (Light Emitting Diode), or an array of LEDs.
  • the electronic state display 26 can include a display screen 34, for example a LED screen and/or a LCD (Liquid Crystal Display) screen.
  • a display screen 34 for example a LED screen and/or a LCD (Liquid Crystal Display) screen.
  • the electronic state display 26 can be configured to display information for each state of the device 10 by means of a specific letter, combination of letters, writings and/or a graphical sign and/ or a symbol or combination of symbols and/or one or more dedicated colors or other visual/optical signals and combinations thereof.
  • the electronic state display 26 can possibly also be configured to supply a specific acoustic signal if the state of the device 10 is varied.
  • the electronic state display 26 can include a user input interface 36, provided with buttons or similar input members for example, so that the user can interact with the electronic state display 26 to modify and set the state displayed manually.
  • the display screen 34 can be the touch-sensitive type and thus make up the input interface 36 itself. In the interests of security, it can be provided that the input interface 36 is only accessible to authorized users, using passwords or other authentication and recognition systems.
  • the electronic state display 26 can be configured to display information on the specific state of the device 10 in a manner that is non-reversible and non-modifiable without authorization, in particular by users who are not authorized. This is to prevent a user, if the device 10 is altered and therefore the electronic state display 26 indicates that the device 10 has been opened and therefore indicates a lack of sterility of the medical instrument 12, from improperly restoring the display of another state on the electronic state display 26.
  • the senor 30 can be selected from a mechanical, electromechanical, electric, electronic, magnetic, optical sensor or a combination of these.
  • the senor 30 can include at least two sensitive elements 38, for example associated, respectively, one to the containing body 14 and one to the closing body 16.
  • one sensitive element 38 can be disposed on the containing body 14 and one sensitive element 38 can be disposed on the closing body 16.
  • the sensitive elements 38 can be disposed in a coordinated and aligned position so that in the closed condition of the closing body 16 they are in proximity, advantageously adjacent, while in the open condition of the closing body 16 they are distanced from each other.
  • the reciprocal position of the two sensitive elements 38 varies in a reliably detectable and repeatable way, and this variation, being correlated to the passage from closed condition to open condition and vice versa, can be directly associated to the opening of the device 10, transmitting a corresponding signal to the electronic state display 26.
  • the senor 30 can include a position sensor, for example a contact sensor or a proximity sensor or similar sensor member.
  • the position sensor can operate as a transducer, being configured to detect the presence or position of a physical object in the immediate vicinity or in contact with respect to a sensitive side of the sensor and to transmit a correlated signal.
  • the contact sensor can be electric, piezoelectric, inductive, capacitive, magnetic, ultrasound or optical.
  • a proximity sensor In the case of a proximity sensor, it can be for example inductive, capacitive, magnetic, ultrasound or optical.
  • the device 10 can include a setting member 40 configured to set the state of processing, re-processing and/or sterilization that has taken place on the medical instrument 12 with the device 10 closed, transmitting a corresponding signal to the electronic state display 26.
  • the setting member 40 can thus be configured to intervene on the electronic state display 26, so that at the end of the processing, re-processing and/or sterilization operations, a state of sterility is set and displayed on the electronic state display 26.
  • the setting member 40 can be configured to proceed automatically to set the state of processing that has taken place.
  • the setting member 40 can be formed by a connector or socket 42, able to support the reception and transmission of an electric feed signal or a data signal, or a combination of electric feed and data signal.
  • the connector or socket 42 can be provided externally to the device 10, for example, in correspondence to the entrances 22.
  • the connector or socket 42 can be connected to the electronic state display 26 to supply the signal.
  • the electric connector or socket 42 can be engaged with a mating socket or connector (not shown) provided on the washer machine with which the device 10 is used, to coincide with the connection of the entrances 22 and, at the end of processing, when the entrances 22 are disconnected, the connector or socket 42 can also be disengaged, or end-of-cycle information can be received.
  • the variation between engagement and disengagement of the connector or socket 42, or the end-of- cycle information can be used to supply an electric and/or data signal to the electronic state display 26 so that it automatically sets the display of process already done.
  • the automatic setting member 40 can be configured to be manually activated by an authorized user who, at the end of the processing, re-processing operations can intervene to set the completed processing state.
  • the automatic setting member 40 can include the input interface 36, possibly also in the version in which it is formed by the display screen 34 in the touch-sensitive version.
  • the automatic setting member 40 can no longer be re-activated or reset to set a "sterile" state of the device 10 and the medical instrument 12 contained therein, unless the device 10 is subjected to another sterilization cycle that restores the sterile condition, in which case the procedure described above is followed.
  • This is to prevent, in the event of an undesired opening and loss of sterility, the possibility of by-passing, in an unnoticed, fraudulent or undesired way, the control and the indication of sterility of the device 10. In this way the device 10 cannot be set to "sterile" by mistake using the automatic setting member 40, despite the electronic state display 26 indicating the loss of "sterility" due to the opening of the device 10.
  • Figs. 1 and 2 are used to describe a plurality of forms of embodiment, which can be combined with all the forms of embodiment described here, in which the device 10 is essentially configured as a portable case and in which the containing body 14 can be a box-like body, generally of a parallelepiped shape, while the closing body 16 can be a closing lid of the case, for example this too of a parallelepiped shape, hinged to the box-like body.
  • gripping handles handles
  • 21 can be provided on one or both sides of the case, typically to facilitate maneuvering and transport.
  • the electronic state display 26 can be provided on an upper face 44 of the closing body 16 (see fig. 1).
  • the on-board electric energy source 28 can be provided integrated or incorporated with the closing lid of the case that makes up the closing body 16.
  • the senor 30 can be provided for example on a lateral face 46 of the device 10, essentially astride a join profile 48 between the containing body 14 and the closing body 16.
  • the sensor 30 has the sensitive elements 38 on one side and the other with respect to the join profile 48, in an aligned position.
  • the setting member 40 can be a connector or socket 42 located on a lateral face 46 of the device 10, for example on the containing body 14 (see fig. 1), or on the closing body 16.
  • Figs. 3 and 4 are used to describe a plurality of forms of embodiment that can be combined with all the forms of embodiment described here, in which the device 10 is configured essentially as a mobile part 50 of a sterilizing machine including at least a fixed part 59 and a mobile part 50 containing at least a medical instrument 12 (not shown in figs. 3 and 4, however comparable for example to that described using figs. 1 and 2).
  • the fixed part 59 includes a first fixed frame 52 on which at least part of a fluid-dynamic circuit to feed and/or discharge fluids is mounted.
  • injection means 53 can be mounted on the fixed part for the controlled injection of fluids into the fluid-dynamic circuit.
  • the fixed part 59 can be installed on a support wall 68 or on another similar or comparable support wall suitable to the purpose.
  • the mobile part 50 is movable reciprocally nearer to/away from the fixed part
  • the mobile part 50 also includes a tank 62 that acts as or defines the containing body 14.
  • the tank 62 is provided with a cavity or housing 65 that acts as or defines the housing 18, suitable to receive the medical instrument 12 to be re-processed.
  • the mobile part 50 also includes at least one lid 55, that acts as or defines the closing body 16, suitable to hermetically close the tank 62.
  • the tank 62 is provided with at least one aperture 64 through which to insert and remove the medical instrument 12.
  • the tank 62 defines, when the lid 55 is closed, the processing chamber in which the medical instrument 12 is washed, dried, and/or sterilized.
  • the closing body 16 is defined or made by the lid 55, that the containing body 14 is defined or made by the tank 62 and that the housing 18 is defined or made by the cavity 65 of the tank 62.
  • the lid 55 is suitable to assume at least a first position, or closed condition, shown for example in fig. 3, in which an internal wall 58 of the lid 55 and the cavity 65 of the tank 62 form said processing chamber, and a second position, or open condition, shown for example in fig. 4, in which the lid 55 is open and the tank 62 is accessible so that the medical instrument 12 can be replaced or removed.
  • the closing body 16, and therefore the lid 55 can be hinged to the containing body 14 that defines the tank 62 so that it can be rotated to move from the first to the second position, or vice versa.
  • the mobile part 50 includes a fluid-dynamic circuit configured to be connected, during use, to the medical instrument 12 and to the tank 62.
  • the fluid- dynamic circuit can include connection means, for example, sockets or entrances 22, to which to connect the connectors of the medical instrument 12 (see fig. 4).
  • the mobile part 50 includes a first mobile frame 56 configured to support at least the containing body 14 with the tank 62, the lid 55 and the fluid-dynamic circuit.
  • the frame 56 of the mobile part supplies in itself a support for the containing body 14 with the tank 62 and the lid 55, which makes it unnecessary to have a support plane in the place in which the medical instrument 12 is used.
  • a similar argument is also valid for when it is necessary to dispose the medical instrument 12 in the tank 62 before it is re-processed.
  • the frame 56 of the mobile part is made in a single body at least with the containing body 14 and the corresponding tank 62. This allows to obtain an extremely solid and resistant structure for its movement.
  • the containing body 14 and the corresponding tank 62 are separate elements from the frame 56 of the mobile part and subsequently mounted integrated on the latter.
  • the frame 56 of the mobile part can develop in a vertical direction to facilitate access to the tank 62 by an operator, to promote ergonomic use, and can also be telescopic, to vary at least the positioning height of the tank 62.
  • the frame 56 of the mobile part can be provided with rolling means 57 for the movement of the mobile part 50, as indicated by the arrow F.
  • the rolling means 57 support the frame 56 of the mobile part and allow it to slide on a support plane.
  • the rolling means 57 allow to move the mobile part 50 nearer to or farther away from the fixed part 59. In this way the mobile part 50 can be transferred from the fixed part 59 to the room where the endoscopic instrument will be used, and vice versa, without having to make any lifting effort.
  • the rolling means 57 can include wheels, pirouetting wheels, rollers, castors, balls, bearings or similar components suitable to the purpose.
  • the fluid-dynamic circuit of the mobile part can be provided with a plurality of entrances 22 mounted on the frame 56 of the mobile part and selectively able to be coupled removably with connectors 54 mounted on the frame 52 of the fixed part 59 to obtain the fluidic communication with the corresponding fluid-dynamic circuit of the fixed part 59 (see fig. 4).
  • the coupled condition of the mobile part 50 with the fixed part 59 also determines a corresponding action of connecting the connectors 54 of the fixed part 59 and the entrances 22 of the mobile part 50.
  • the two fluid-dynamic circuits can be connected to each other, allowing the process fluids to pass to and from the medical instrument 12 and to and from the tank 62.
  • the two fluid-dynamic circuits are configured to allow at least one of either washing, sterilization liquids, purge gas, or gas to check the airtight seal to pass through them.
  • the two fluid-dynamic circuits can be configured to also allow the discharge of washing liquids present in the tank 62.
  • the mobile part 50 and the fixed part 59 include anchoring means 77 configured to removably constrain the frame 52 of the fixed part 59 to the frame 56 of the mobile part 50, when the fixed part 59 and the mobile part 50 are coupled to each other.
  • the fixed part 59 can include a control and management device 91 (fig. 4), possibly governed by a user interface, and configured to control and manage the washing process of the medical instrument 12.
  • the control and management device 91 can supply a start-of-cycle signal, and an end-of-cycle signal, the latter usable in the device 10 to set, manually or automatically, the display of completed treatment on the electronic state display 26.
  • the electronic state display 26 can be provided externally on the lid 55 (see fig. 3 for example).
  • the electronic state display 26 can be provided on the tank 62 in an easily visible position for the user.
  • the source of electric energy 28 is on board, according to the present description, it can be provided integrated into the lid 55, or in another zone of the tank 62 or the frame 56 of the mobile part.
  • the senor 30 can be associated with the lid 55 and the tank 62, providing a sensitive element 38 for example on the lid 55 and a sensitive element 38 on the tank 62 (see fig. 4 for example).
  • the setting member 40 can be a connector or socket 42 provided at the back on the mobile part 50, for example in proximity to the entrances 22.
  • the connector or socket 42 connecting for example to a mating socket or connector of the fixed part 59, can thus receive a useful signal from the fixed part 59, for example from the control and management device 91, or, as described above, the setting member 40 can be part of the input interface 36.

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  • General Chemical & Material Sciences (AREA)
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  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

La présente invention concerne un dispositif pour traiter et transporter des instruments médicaux de façon protégée qui comprend un corps de confinement (14), dans lequel un instrument médical (12) est placé, et un corps de fermeture (16), dans lequel le corps de confinement (14) et le corps de fermeture (16) sont configurés de façon mobile l'un par rapport à l'autre, afin de définir un état hermétiquement fermé et un état ouvert. Le dispositif comprend au moins un capteur (30) configuré pour détecter automatiquement une variation entre l'état ouvert et l'état hermétiquement fermé et pour transmettre un signal correspondant, et un affichage d'état électronique (26) configuré pour recevoir le signal provenant du capteur (30) et pour afficher à l'extérieur des informations concernant l'état actuel associées spécifiquement au signal reçu.
PCT/IB2015/050709 2014-01-30 2015-01-30 Dispositif pour traiter et transporter des instruments médicaux de façon protégée WO2015114578A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US15/115,788 US20170172397A1 (en) 2014-01-30 2015-01-30 Device to process and transport medical instruments in a protected manner
EP15710884.6A EP3110460B1 (fr) 2014-01-30 2015-01-30 Dispositif pour traiter et transporter des instruments médicaux de façon protégée

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ITUD20140013 2014-01-30
ITUD2014A000013 2014-01-30

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USD1011297S1 (en) 2021-04-19 2024-01-16 eMoMo Technology Co., Ltd. Multi-function disinfector socket
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US20170172397A1 (en) 2017-06-22
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